Papillary muscle position control devices, systems, &amp; methods

ABSTRACT

Papillary muscle position control devices, systems, and methods are provided. According to an exemplary embodiment, a papillary muscle position control device generally comprises a first anchor, a second anchor, and a support structure. The first anchor can be configured to fixedly connect to an in situ valve of a heart ventricle. The second anchor can be configured to fixedly connect to a muscle wall of the valve. The support structure can be configured to have an adjustable length and be coupled to the first anchor and second anchor such that adjusting the length of the support structure varies a distance between the first anchor and the second anchor. Other embodiments are also claimed and described.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.12/096,948, filed 24 Oct. 2008, which is a 35 U.S.C. §371 U.S. NationalStage of International Application No. PCT/US2006/062185 filed 15 Dec.2006, which claims priority to and the benefit of U.S. ProvisionalApplication No. 60/750,561, filed 15 Dec. 2005, all of which are herebyincorporated by reference in their entirety as if fully set forth below.

TECHNICAL FIELD

The various embodiments of the present invention relate generally toheart valve repair devices and methods, and more particularly, todevices and methods capable of positioning and controlling papillarymuscles of an atrioventricular valve.

BACKGROUND

Cardiovascular disease accounts for nearly fifty percent of deaths inboth the developed world and in developing countries. The risk of dyingfrom heart disease is greater than the risk from AIDS and all forms ofcancer combined. Cardiovascular diseases cause approximately 12 milliondeaths in the world each year. It is the leading cause of death in theUS, killing approximately 950,000 people each year. It also accounts fora significant amount of disability and diminished quality of life.Indeed, approximately 60 million people in the US alone have some formof heart disease. A great need, therefore, exists for the advancement ofdevices, methods, systems, and procedures to cure, treat, and correct awide variety of forms of heart disease.

Normal heart function primarily relies upon the proper function of eachof the four valves of the heart, which allow blood to pass through thefour chambers of the heart. These four valves have cusps or leaflets,comprised of fibrous tissue, which attach to the walls of the heart. Thefour chambers of the heart include the right atrium and left atrium, theupper chambers, and the right ventricle and left ventricle, the lowerchambers. The four valves, controlling blood flow in and between thechambers, include the tricuspid, mitral, pulmonary, and aortic valves.Heart valves are complex structures that consist of moveable leafletsthat open and close the valve. For example, the mitral valve has twoleaflets and the tricuspid valve has three leaflets. The aortic andpulmonary valves have three leaflets that are more aptly termed “cusps,”as they have a half moon shape.

The cardiac cycle involves the pumping and distribution of bothoxygenated and deoxygenated blood within the four chambers. Oxygenatedblood, enriched by the lungs, reenters the heart into the left atrium orleft upper chamber. The mitral valve, a one way inflow valve, thendirects the oxygenated blood into the left ventricle. The contraction ofthe left ventricle pumps the oxygenated blood through the aortic valve,into the aorta, and into the blood stream. When the left ventriclecontracts the mitral valve closes such that the oxygenated blood passesinto the aorta. Deoxygenated blood returns from the body via the rightatrium. This deoxygenated blood flows through the tricuspid valve intothe right ventricle. When the right ventricle contracts, the tricuspidvalve closes and the deoxygenated blood is pumped through the pulmonaryvalve. Deoxygenated blood is directed to the pulmonary vascular bed foroxygenation, and the cardiac cycle repeats itself.

Mitral valve regurgitation is one the most prevalent heart diseaseconditions, which has many levels of severity. After 55 years of age,some degree of mitral regurgitation is found in almost 20% of men andwomen who have an echocardiogram. Mitral valve regurgitation, or mitralregurgitation, is a condition in which the mitral valve doesn't closetightly. It results from the failure of the mitral valve leaflets tocompletely close when the left ventricle contracts, resulting in theflow of blood back into the left atrium due to an overworked leftatrium. This allows blood to flow backward in the heart which in turncan lead to serious heart conditions such as congestive heart failureand serious heart rhythm irregularities (arrhythmias). Mitral valveregurgitation is also a progressive condition that, if not corrected,can be fatal.

Also, approximately 40% of patients having some form of surgery in anattempt to correct mitral valve regurgitation end up with either 1+ or2+ regurgitation measurements. While this may result in improvedregurgitation characteristics, the future for these patients can involveadditional surgery as their improved regurgitation characteristics willtypically degrade over time as 1+ or 2+ regurgitation can negativelyaffect heart valve functionality.

The function of an atrioventricular valve, like the mitral valve,involves the complex interaction of numerous components, including theleaflets, chordae tendineae, and papillary muscles. If one of thecomponents or functions of the complicated interaction fails, thenmitral valve regurgitation can result. For example, excess leaflettissue, inadequate leaflet tissue, or restricted motion of the leafletscan lead to mitral regurgitation.

Techniques currently exist to assist in correcting the shape of a mitralvalve to control the geometries of mitral valve shape. For example, oneconventional technique includes surgically reshaping the ventrical withextensive surgical manipulation. Another conventional technique involvesreshaping the geometry of the annulus of the ventrical with a ring orother annuloplasty device. Another conventional device is the CoapsysDevice manufactured by Myocor, Inc. (Maple Grove, Minn. USA) anddescribed in U.S. Pat. Nos. 6,332,893 and 7,077,862.

These conventional techniques, while serving their respective purposes,do posses drawbacks. For example, certain of these conventionaltechniques, can at times, require extensive surgery which can increasepossible associated risks to patients. Also, these techniques do notutilize an atrioventricular valve's papillary muscles to assist inreshaping valve geometry by apically adjusting a papillary muscle tocontrol valve regurgitation. Further, these conventional devices do notenable fine tuning adjustments to be made on a beating heart to control,reduce, and eliminate blood regurgitation in atrioventricular valves.

Accordingly, there is a need for devices and methods to control theposition of papillary muscles relative to an annulus of anatrioventricular valve. In addition, there is a need for devices andmethods to reposition a papillary muscle using a positioning device toassist in controlling, reducing, and eliminating blood regurgitation.Still yet, there is a need for devices and processes enabling apicaladjustability of positions between papillary muscles and an annulus ofan associated atrioventricular valve. There is still yet a further needfor devices and methods enabling fine tuning adjustments to be made on abeating heart to control, reduce, and eliminate blood regurgitation inatrioventricular valves. It is to the provision of such papillary musclepositioning devices, systems, processes, and methods that the variousembodiments of the present invention are directed.

BRIEF SUMMARY

Embodiments of the present invention provide devices and methods capableof controlling positioning of papillary muscles and an annulus of anatrioventricular valve. According to some embodiments, the presentinvention comprises methods, implants, and tools enabling control of arelative position between papillary muscles of an atrioventricular valveand an associated annulus to aid in reshaping the geometry of theannulus to control, reduce, and eliminate blood flow regurgitation. Someembodiments can be used with an annuloplasty device, and otherembodiments may not use an annuloplasty device.

Generally described, a papillary muscle positioning device can comprisea first anchor, a second anchor, and a support structure. The termanchor is at times used synonymously with pad herein. The first anchorcan be configured to fixedly connect to an in situ valve of a heartventricle, and the second anchor can be configured to fixedly connect toa muscle wall of the valve. The support structure can be configured tohave an adjustable length and coupled to the first anchor and secondanchor. In this configuration, the length of support structure can beadjusted to vary a distance between the first anchor and the secondanchor, which in turn can vary the distance between the in situ valveand the muscle wall.

A device embodiment of the present invention can also include additionalfeatures. For example, the first anchor can be an annuloplasty ringsecured to an annulus of the valve. The second anchor can penetrate themuscle wall at a papillary muscle to enable the adjustable lengthsupport structure to vary a distance between the papillary muscle andthe first anchor. Still yet, a device can further comprise one of aninternal restraint disposed within the valve or an external restraintdisposed about an exterior of the valve. These restraint can alter alateral position of the papillary muscle.

Still yet other features are also contemplated for devices according tothe present invention. For example, the support structure can have agenerally circular or generally square cross-sectional shape. The firstanchor and the second anchor can comprise a lock to engage the supportstructure. The support structure can comprise an internal locking regionto enable the length of the support structure to be locked of fixed. Thefirst anchor can be an annulus anchor comprising flexible arms thatextend at least partially around a perimeter of the annulus. The firstanchor can comprise a connection mechanism adapted to connect to anannuloplasty device. And the support structure can comprise interiorcorresponding threaded regions enabling the length of the supportstructure to be adjusted.

Embodiments of the present invention also include methods to position apapillary muscle. Broadly described, a method to control a distancebetween a valve muscle and a valve annulus in a human heart can compriseproviding a device configured to be positioned between a valve muscleand a valve annulus; disposing the device between the valve muscle andthe valve annulus; and adjusting a length of the device to alter thedistance between the valve muscle and the valve annulus. A positioningmethod can also comprise attaching the device to at least one of anannulus ring or a papillary muscle. Another feature of a positioningmethod can include rotating one end of the device relative to anotherend of the device to adjust the length of the device.

Other method embodiments of the present invention can include additionalsteps. For example, a method can comprise flexing one end of the devicerelative to another end of the device to adjust the length of thedevice. Also, a method can comprise attaching the device to at least oneexterior area proximate a papillary muscle of the valve muscle, orproviding a tension member to tension the valve muscle to change theshape of the valve muscle. The valve muscle can be a papillary musclehaving a tip, and one end of the device can be attached to the tip ofthe papillary muscle. Also, one end of the device can be attachedproximate the base of the papillary muscle one end of the device cansecured to at least a portion of the exterior of the papillary muscle.The device can be provided with corresponding internal locking membersadapted to adjust the length of the device according to some methods.And according to some methods, the device can comprise multiple supportstructures each connected to a separate papillary muscle. The multiplesupport structures can have adjustable lengths to alter the distancebetween the valve muscle and the valve annulus.

According to another embodiment of the present invention, a papillarymuscle position system can comprise a first support structure and afirst adjustment mechanism. The first support structure can be coupledto a first papillary muscle and the first adjustment mechanism can becoupled to the first support structure to adjust the length of the firstsupport structure to position the first papillary muscle. A system canalso comprise a second support structure coupled to a second papillarymuscle, and a second adjustment mechanism coupled to the second supportstructure to adjust the length of the second support structure toposition the second papillary muscle. A system can also include anannuloplasty device coupled to an annulus of an atrioventricular valveand coupled to the first and second adjustment mechanisms. In thisconfiguration, the first and second adjustment mechanisms can bepositioned proximate the annulus. Also, a system can comprise an anchordisposed proximate the first papillary muscle. The anchor can receivethe first support structure so that the first support structure iscoupled to the first papillary muscle.

Other features are also contemplated according to additional systemembodiments. For example, an anchor can be attached to one of theexterior of the first papillary muscle or beneath the first papillarymuscle on an exterior surface of an associated valve wall. Also, thesupport structure can be a suture that is looped about the firstpapillary muscle. In another configuration, the first adjustmentmechanism can comprise threaded components that interact with each otherto adjust a length of the first support structure. One of the treadedcomponents can be coupled to the first support structure. Alternatively,the first adjustment mechanism can comprise a pin to lockably engage thefirst support structure to fix the length of the first supportstructure. The first support structure can be a semi-rigid elongated rodthat flexes in a substantially unidirectional manner. And the firstsupport structure can house an internal security wire to secure thefirst support structure according to some embodiments.

Still yet, other embodiments of the present invention include additionalmethod embodiments. According to other method embodiments, a method toposition a papillary muscle can comprise coupling a first end of asupport structure to a papillary muscle; coupling a second end of thesupport structure proximate an annulus of a valve; and adjusting theposition of the papillary muscle in a substantially apical directionwith an adjustment device so that the papillary muscle is positionedcloser to the annulus. A method can also comprise providing an anchorproximate the papillary muscle, the anchor to receive the first end ofthe support structure. A method can also include coupling the adjustmentdevice to an annuloplasty device coupled to the annulus. Another methodembodiment can comprise positioning the adjustment device proximate atleast one of the papillary muscle or the annulus. Compressing apapillary muscle to alter at least one of the shape, position, or lengthof the papillary muscle can also be included in a method embodiment.

In yet another embodiment of the present invention, a papillary musclepositioning device generally comprises a support structure and anadjustment mechanism. The support structure can be disposed between apapillary muscle and an annulus. The adjustment device can lockablyengage the support structure to alter the length of the supportstructure and to fix the length of the support structure at an alteredlength. The adjustment device can be attached proximate to at least oneof the annulus, an annuloplasty device coupled to the annulus, thepapillary muscle, or disposed partially within the papillary muscle.Also, at least one of the support structure or the adjustment device cancomprise threaded components. In this configuration, the threadedcomponents can interact with each other in response to an appliedmechanical force such that one of the threaded components can moverelative to and lockably engage the other threaded component.

Accordingly, it is an aspect of some embodiments of the presentinvention to provide a cardiovascular implant to control the geometry,size, and area of an annulus of an atrioventricular valve and therelative position between papillary muscles and an annulus of anatrioventricular valve.

Another aspect of some embodiments of the present invention is tocontrol the relative position between papillary muscles and an annulusof an atrioventricular valve.

Another aspect of some embodiments of the present invention is toprovide a cardiovascular implant to control the apical position betweenpapillary muscles and an annulus of an atrioventricular valve

Other aspects according to some embodiments of the present inventioninclude providing a cardiovascular implant to control the chordal forcedistribution of an atrioventricular valve or to reduce the length of apapillary muscle.

Still yet other aspects according to some embodiments of the presentinvention include providing a cardiovascular implant which may bedelivered percutaneously or thorocoscopically to control a relativeposition between papillary muscles and an annulus of an atrioventricularvalve.

Still yet another aspect according to some embodiments of the presentinvention includes providing a cardiovascular implant that can be finetuned and adjusted on a beating heart to control, reduce, and eliminateblood flow regurgitation.

Other aspects and features of embodiments of the present invention willbecome apparent to those of ordinary skill in the art, upon reviewingthe following description of specific, exemplary embodiments of thepresent invention in conjunction with the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a perspective view of a mitral valve and certainother components associated with a mitral valve.

FIG. 2 illustrates a spatial reference system based on normal papillarymuscle position that the inventors used during a study of papillarymuscle position.

FIG. 3 illustrates a device to control the position of multiplepapillary muscle including an annular ring according to some embodimentsof the present invention.

FIG. 4 illustrates a device to control the position of a papillarymuscle including an annulus support anchor according to some embodimentsof the present invention.

FIG. 5 illustrates a device to control the position of a papillarymuscle including an annular ring and an external restraint according tosome embodiments of the present invention.

FIG. 6 illustrates a device to control a position of a papillary muscleincluding a support that does not penetrate a papillary muscle accordingto some embodiments of the present invention.

FIG. 7 illustrates a device to control a position of a papillary muscleincluding support structures having variable lengths according to someembodiments of the present invention.

FIG. 8 illustrates a device to control a position of a papillary muscleincluding internally threaded support structures according to someembodiments of the present invention.

FIG. 9 illustrates yet another device to control a position of apapillary muscle according to some embodiments of the present invention.

FIG. 10 illustrates a device to control a position of a papillary muscleincluding a compression force system according to some embodiments ofthe present invention.

FIG. 11 illustrates a device to control a position of a papillary muscleincluding another compression force system according to some embodimentsof the present invention.

FIG. 12 illustrates a logical flow diagram depicting a method embodimentof the present invention capable of reforming an atrioventricular valveby controlling position of an associated papillary muscle.

DETAILED DESCRIPTION OF PREFERRED & ALTERNATIVE EMBODIMENTS

Referring now to the figures, wherein like reference numerals representlike parts throughout the several views, exemplary embodiments of thepresent invention will be described in detail. Throughout thisdescription, various components may be identified having specific valuesor parameters, however, these items are provided as exemplaryembodiments. For example, it should be understood that while someembodiments are discussed with specific reference to mitral valves,embodiments of the present invention can be utilized in conjunction withany atrioventricular valve. Thus, the exemplary embodiments do not limitthe various aspects and concepts of the present invention as manycomparable parameters, sizes, ranges, and/or values may be implemented.

FIG. 1 illustrates a mitral valve 100. As shown, the mitral valve 100includes a mitral annulus 105, an anterior mitral leaflet 110, aposterior mitral leaflet 115, chordae tendineae 120, and medial andlateral papillary muscles 135, 140. Mitral annulus refers to theelliptical region of the valve leaflet attachment contiguous with thebase of the left atrium. The mitral annulus 105 is composed of anteriormitral annulus 125 and a posterior mitral annulus 130. The mitralannulus 105 is saddle shaped with the basal portions of the saddlelocated medially and laterally. Attached to the anterior mitral annulus125 is the anterior mitral leaflet 110 and attached to the posteriormitral annulus 130 is the posterior mitral leaflet 115. The regionswhere the anterior mitral leaflet 110 and the posterior mitral leaflet115 meet are termed the lateral commissure 145 and the medial commissure150.

The various components of the mitral valve 100 depicted in FIG. 1control blood flow within a heart between the left atrium and leftventricle of the heart. In a normal mitral valve, when the atrialpressure exceeds the ventricular pressure, the valve leaflets 110, 115open in to the ventricle. When the ventricle pressure increases, theleaflets meet and close, covering the area of the valve annulus 105.Therefore, as shown in FIG. 1, the anterior mitral leaflet 110 and theposterior mitral leaflet 115 will open during systole to allow blood toflow through the mitral valve 100. Conversely, the anterior mitralleaflet 110 and the posterior mitral leaflet 115 will overlap and closethe mitral valve 100 to prevent regurgitation, into the left atrium. Aspeople age and due to other factors, the mitral valve 100 and itscomponents can stop functioning correctly thereby allowing regurgitationof blood.

As part of their discovery of the various embodiments of the inventiondiscussed herein, the inventors performed several studies. These studiesled the inventors to conclude that controlling the position of papillarymuscles of an atrioventricular valve can enable an abnormalatrioventricular valve to have normal functional characteristics. Withrespect to a mitral valve, such normal functional characteristicsinclude improved closure between valve leaflets 110, 115 (or leafletmalcoaptation) to help control, reduce, and eliminate regurgitationbetween the left atrium and left ventricle of the heart. In addition todiscussing various embodiments of the present invention below, certainof the inventor's study results and methodologies are also provided tofurther explain concepts and details associated with various embodimentsof the present invention.

Discussion of Study Methodologies and Study Results

The inventors studied seven human and four porcine valves using a leftheart simulator with a standard atrial model. Variations in chordalforce and mitral regurgitation due to papillary muscle displacementutilize a normal papillary muscle position as a reference for the study.The papillary muscles were displaced to eight different papillary musclepositions. FIG. 2 illustrates a spatial reference system based on normalpapillary muscle position that the inventors used during a study ofpapillary muscle.

The reference for the displacements illustrated in FIG. 2 is the normalpapillary muscle position. All papillary muscle displacements weresymmetrical in the study; therefore both papillary muscles weredisplaced equally to reach each position. All papillary muscle positionswere constructed from 5 mm vectorial displacements from the normalposition in the apical, lateral, and posterior directions in the study.Illustrated in FIG. 2 is a displacement reference system 205 that showsthe various displacement positions used by the inventors in theirstudies. The below table (Table I) summarizes the vectorial compositionsof the papillary muscles that the inventors used with the displacementreference system 205 illustrated in FIG. 2.

TABLE I Papillary Muscle Displacement (millimeters) Position ApicalLateral Posterior 000 0 0 0 005 0 0 5 050 0 5 0 055 0 5 5 500 5 0 0 5055 0 5 550 5 5 0 555 5 5 5

During the cardiac cycle, the mitral valve is held within a very dynamicenvironment which is described by annulus displacement, ventricularmotion, and papillary muscle contraction. Within this environment, thebasal chords maintain a relatively constant distance from the tips ofthe papillary muscles to the annulus, aiming to maintain overall valvegeometry and isolating the motion of the leaflets from the surroundingenvironment movement. The geometrical and anatomical construct of themitral valve must ensure that the chords controlling coaptation andespecially those involved in the appropriate sealing of the valve areless sensitive to the changing environment. Therefore, the intermediatechords are less sensitive to changes in papillary muscle position thanthe basal chords, whereas the marginal chords are the least sensitive ofall chordal types to papillary muscle position variations.

These characteristics were clearly shown by the standard deviations ofthe forces of the chords when different papillary muscle positions werecompared. In addition, the direction of displacement of the papillarymuscles was directly related to which chord type presented alteredtensions. For example, apical displacement affected tension on thesecondary chords of both leaflets, whereas posterior displacement tendedto reduce the force on chords which inserted into the posterior leaflet.The tensions on chords which inserted near the annulus were affected bydisplacement of the papillary muscles in all directions. Apicaldisplacement significantly increased the tension present on the anteriorstrut chord. When the papillary muscles are displaced apically, thecoaptation geometry of the mitral valve changes. Thus, apicaldisplacement generates tented leaflet geometries, and under a tentedgeometry, the intermediate chords restrict leaflet motion.

The study results for the anterior strut chord showed that as apicaldisplacement of the papillary muscles tented the leaflets andsignificantly increased the load the anterior strut chord. The decreasein force when repositioning the papillary muscles from position 500 toposition 505 was probably related to a redistribution of the loadbetween chords. Posterior papillary muscle displacement decreased thetension on the posterior intermediate chord by approximately 37%. Thispapillary muscle relocation shifted the coaptation line posteriorly,reducing the area of the orifice covered by this leaflet and decreasingthe insertion angle of this chord. Both of these changes reduced theresultant force vector. The increase in tension associated with position500 is explained by the same tenting described for the anterior strutchord.

Combined apical-lateral displacement induced a significant increase intension due to tenting of the leaflet and the stretching and redirectionof the posterior intermediate chord. This effect was reduced in position555 because of the posterior motion associated with this position. Theforce on the anterior marginal chord and posterior marginal chord wasrelatively homogeneous for the different papillary muscle positions. Asthe marginal chords control coaptation in the tip of the leaflet,tension in them may be less sensitive to changes in papillary muscleposition as the mitral valve is designed to operate in a highly dynamicenvironment. The tension on the posterior basal chord was highlysensitive to papillary muscle displacement. Posterior displacementreduced the tension on the posterior basal chord as it redirected theangle of the chord. This motion reduced the septal lateral component offorce, and thus reduced the overall resultant force. As chordaetendineae have a non-linear mechanical response to elongation, apicaldisplacement increased peak systolic tension on the basal posteriorchord because of pre-straining. A pre-strained chord will be subjectedto a higher tension for a similar strain during coaptation. Lateraldisplacement of the papillary muscles reduced the force on the basalposterior chord. This reduction was probably due to a redistribution ofthe load with other chords.

The commissural chord selected experiments inserted near the annulus andbelow the septa lateral midpoint of the valve (posterior section of thevalve); therefore, trends in force variation due to papillary muscledisplacement were similar to those present in the basal posterior chord.Similarly, pre-straining increased the force on the basal posteriorchord during apical motion of the papillary muscles. In addition, bothposterior and lateral relocation of the papillary muscles decreased theforce on these chords. The relative contributions of these motions(lateral, posterior) to the force on the commissural chord should bedifferent than the contributions to the force of the basal posteriorchord because of their different angle and location of insertion on thevalve.

Finally, positions associated with apical displacement (500, 505, 550,555), showed clinically significant levels of mitral regurgitation(>20%). Other positions associated with lateral or posteriordisplacement of the papillary muscle did not induce clinically relevantmitral regurgitation. Only position 505 associated with both lateral andposterior displacement showed an increase in regurgitation.

The study results revealed the effects of papillary muscle displacementon the peak systolic tension present on different types of chordaetendineae. Apical motion increased peak systolic tension on thesecondary chords, whereas chords on the posterior side of the valve weresubject to a reduction in peak systolic tension after posterior motionof the papillary muscles. Chords which insert near the annulus wereaffected by lateral, posterior, and apical displacement of the papillarymuscles. The study results also showed that variation in tension due topapillary muscle relocation decreased with increasing distance ofchordal insertion from the mitral annulus. Chords which insert near theannulus are the most sensitive to variations in papillary muscleposition, whereas chords which insert into the tip leaflet are the leastsensitive to papillary muscle relocation. Additionally, mitralregurgitation was associated with apical displacement of the papillarymuscles, and therefore may also be associated with increased tension ofthe intermediate or basal chords.

A second study on papillary muscle displacement was designed toelucidate the interaction between annular dilation and both symmetricaland asymmetrical papillary muscle displacement. The porcine mitralvalves mounted in a normal sized annulus and in a normal papillarymuscle position closed efficiently, with a central coaptation length ofapproximately 15.8±2.1 mm, and without echodetectable mitralregurgitation. With dilated mitral annuli and/or displaced papillarymuscles, regurgitation occurred. The measured central coaptation lengthsdecreased with annular dilation and papillary muscles displacement.Coaptation length reached its minimum value of approximately 0.4±0 5 mmwhile using the large annulus and under symmetrical papillary muscledisplacement.

Mitral regurgitation volume increased with annular dilation andpapillary muscle displacement. The volume reached approximately18.5±10.2 ml with the large annulus under symmetrical papillary muscledisplacement. Regurgitation volume correlated with central coaptationlength (r=approximately 0.71). Asymmetric tethering of the posteriorpapillary muscle led to mitral regurgitation volumes of approximately4.1±1.9; 12.4±4.3; and 20.1±12.5 ml for the normal, medium, and largeannuli, respectively. Asymmetric anterior papillary muscle tethering ledto regurgitation volumes of approximately 3.6±1.8; 10.5±3.5; and19.6±9.9 ml for the normal, medium, and large annuli, respectively.

Increased distance between the anterior and posterior annuli in thedilated mitral annular model decreased leaflet coaptation length,shifting the coaptation line towards the edges of the leaflets. Thisdescribes how a larger orifice has to be covered by the same amount oftissue; therefore the overlapping of the leaflets is reduced. Clinicalobservations of extensive left ventricular infarction, or leftventricular dilation, have shown that both papillary muscles move in theradial direction away from the center of the left ventricle. The apicalposterior lateral papillary muscle displacement performed in theinventor's study simulated this condition. Indeed, apical displacementwas restricted by the chordae tendineae because of their stiffness. Thisis consistent with measurements by others, who observed that thedistance between the tips of the papillary muscle and the mitral annulusis relatively constant. Both the anterior and posterior mitral leafletswere restricted during systole with symmetrical papillary muscledisplacement.

Symmetrical papillary muscle displacement induced the coaptation line toshift towards the ventricle parallel to the annulus plane, and producedleakage gaps and regurgitation in the central region of the valve. Thisis similar to the phenomenon observed in patients with extensivemyocardial infarction, where the area of the roots of both papillarymuscles may be affected, leading to subsequent relocation. Regionalmyocardial infarction produces local effects which may result in unevenpapillary muscle displacement, especially if the area affected involvesonly one of the papillary muscles. Asymmetric papillary muscledisplacement restricted leaflet motion on the tethered side of thevalve. Commissural leaflets appeared to be more affected by papillarymuscle displacement, because they are shorter than the posterior andanterior leaflets, and are therefore characterized by a smallercoaptation area. With a dilated annulus and under papillary muscletethering, the commissural leaflets decreased their coaptation area anddeveloped leakage gaps. Furthermore, tethering only one papillary muscle(i.e., asymmetric tethering) led the commissural leaflet on the oppositeside of the valve to bulge towards the atrium during systole, as aresult of relative slackness in the chordae tendineae in this area ofthe valve.

These observations, which describe irregular tenting and bulging of theleaflets, are consistent with observations in experiments using anin-vivo ovine model of acute infarction of the posterior leftventricular wall. Increased tension on one commissural side leads to anuneven coaptation with off-centered gaps and consequently significantmitral regurgitation on the tethered side of the valve, which is alsoconsistent with clinical observations, where the regurgitation Jets werefound on the side of the infarction. Ischemic myocardial infarction mayalso restrict anterior leaflet motion and generated posterior leafletprolapse.

Leaflet geometry during valve closure was affected by annular dilationand papillary muscle position. Symmetrical papillary muscle displacementcaused leakage gaps in the central region of the coaptation line andsubsequent regurgitation. Asymmetric papillary muscle tethering causedtethered side leakage gaps and moderate to severe regurgitation. Tentingand bulging of the commissural leaflets generated vulnerable points formitral regurgitation under these conditions. In general under similarconditions of annular dilation asymmetric papillary muscle displacementinduced larger regurgitation volumes than symmetric papillary muscledisplacement.

In summary, the inventor's studies showed that papillary muscledisplacement are associated with mitral regurgitation. Increased annulararea reduces leaflet coaptation resulting in regurgitation. In additionpapillary muscle displacement can produce leaflet malcoaptaion andsubsequent regurgitation. The inventors also found that theregurgitation due to papillary muscle displacement was more severe whenthe papillary muscles are displaced asymmetrically. The inventors alsodiscovered that apical displacement is an important determinant ofregurgitation due to papillary muscle displacement.

Apical displacement affects the tension on the intermediate chordsrestriction leaflet motion. Thus, controlling papillary muscle positionwas found to be a factor to correct mitral regurgitation. Consideringthat there is a constant distance between the commissural areas of theannulus and papillary muscles, this distance can be controlled by thebelow discussed various embodiments of the present invention to restorenormal valve functions to an abnormal functioning atrioventricularvalve.

Discussion of Embodiments

Turning now specifically to the other figures, FIG. 3 illustrates adevice 300 that includes papillary muscle support structures to controlpapillary muscle position according to some embodiments of the presentinvention. The device 300 is configured to enable control of a distancealong line L between the annulus and the tip of the papillary muscles.The distance along line L is at times referred to herein as the apicaldistance between papillary muscles and an associated atrioventricularvalve.

As shown in FIG. 3, the device 300 has various components. Thesecomponents can include an annuloplasty device 305, a first supportstructure 310, a second support structure 315, a first papillary musclepad 320, a second papillary muscle pad 325, a first ventrical wall pad330, and a second ventrical wall pad 335. As shown, the two supportstructures 310, 315 are disposed and coupled between the annuloplastydevice 305 and a respective papillary muscle pad and ventrical pad. Morespecifically, the first support structure 310 is coupled between theannuloplasty device 305, and the first papillary muscle pad 320 and thefirst ventrical wall pad 330. Similarly, the second support structure315 is coupled between the annuloplasty device 305, and the firstpapillary muscle pad 325 and the first ventrical wall pad 335. Asdiscussed below in greater detail, other embodiments may utilize asingle support structure, may not include an annuloplasty device, or mayutilize different mechanisms to attach to an annuloplasty device and apapillary muscle.

Preferably the device 300 enables the support structures 310, 315 tomove so that the length of line L can vary. For example, the papillarymuscle pads 320, 325 and the ventrical wall pads 330, 335 can be adaptedto enable movement of the support structures 310, 315 such that thelength of the support structures can be adjusted or varied. According tosome embodiments, one or both of the papillary muscle pads 320, 325 andventrical wall pads 330, 335 can include locking mechanisms or otherpressure mechanisms to enable the distance between a papillary muscleand an annulus to be adjusted and fixed at a certain length. Forexample, the pads can comprise a clamping or pin mechanism that will fixthe support structures 310, 315 in a static position. The movement ofthe papillary muscle relative to the annulus can alter or change thegeometric shape of valve leaflets to control, reduce, and eliminateregurgitation.

The annuloplasty device 305 can have various characteristics. Indeed,according to some embodiments, the annuloplasty device 305 can have aproximal ring 307. The proximal ring 307 may be rigid, flexible,complete, partial, or comprise multiple links. The proximal ring 307 mayalso be constructed of a biocompatible material or of a nonbiocompatible material covered by a biocompatible layer. For example,the proximal ring 307 may be constructed of a biocompatible metal orbiocompatible polymer. The proximal ring 307 may be covered by asuturing layer which will allow it to be attached using sutures to theannulus. The proximal ring 307 may be attached on or to the annulus ofan atrioventricular valve using clamps, hooks, sutures, or otheranchoring mechanisms.

As mentioned above, the support structures 310, 315 can be coupled tothe annuloplasty device 305 according to some embodiments. Theannuloplasty device 305 may permanently or temporarily be coupled to orengage the support structure 310, 315. For example, the supportstructures 310, 315 can be manufactured integrally with the annuloplastydevice 305 to form a unitary device or the supports structures 310, 315can be manufactured separately from the annuloplasty device 305. Forembodiments where the support structures 310, 315 are not permanentlycoupled to the annuloplasty device 305, the support structures 310, 315can include attachment members that enable the support structures 310,315 to connect to any annuloplasty device. This advantageous feature ofcertain embodiments of the present invention enables use with anannuloplasty device already deployed or implanted within a patient, oran annuloplasty device manufactured by a different manufacturer.Alternatively, the support structures 310, 315 can comprise clamps toenable the support structures 310, 315 to clamp onto an annuloplastydevice 305. Other techniques for coupling support structures to anatrioventricular valve annulus or annuloplasty device are discussedbelow.

The support structures 310, 315 of the device 300 can also have variouscharacteristics. As mentioned above, and as shown in FIG. 3, the supportstructures 310, 315 can be connected to a papillary muscle and theannuloplasty device 305. Alternatively, the support structures 310, 315may be connected between a papillary muscle and an annulus of anatrioventricular valve or a wall of an atrioventricular valve. Thesupport structures 310, 315 may be an elongated rod, wire, suture, ormany other similar tension members. The support structures 310, 315 maybe constructed of numerous materials, including but not limited to, abiocompatible metal, biocompatible polymer, biocompatible silk, otherbiocompatible materials, collagen, bio-engineered chords, or otherbio-engineered materials. The support structures 310, 315 can also beslidably coupled to or otherwise interact with the pads 320, 325, 330,335 enabling the apical distance L to be adjusted and fine tuned afterimplantation of the device 300.

The pads 320, 325, 330, 335 of device 300 can have variouscharacteristics. More specifically, the papillary muscle pads 320, 325preferably enable the support structures 310, 315 to pass through (orpenetrate) a papillary muscle so that the papillary muscle is notdamaged and so that the support structures 310, 315 do not entangleamong the several chords associated with a papillary muscle. As shown,the papillary muscle pads 320, 325 can be attached or secured to a tipof a papillary muscle. In other embodiments, the papillary muscle pads320, 325 may have other configurations that allow the papillary musclepads 320, 325 to be attached or secured along the exterior of orproximate the base of a papillary muscle. An exemplary configuration caninclude a donut shaped papillary muscle connection device. The ventricalwall pads 330, 335 preferably provide a support on the exterior of aventrical wall so that a support structure can be securedly affixed tothe ventrical wall pads 330, 335. The ventrical wall pads 330, 335 canhave various lengths.

The pads 320, 325, 330, 335 of device 300 can connect to the supportstructures 310, 315 in numerous configurations. According to someembodiments, the attachment pads 320, 325, 330, 335 can include anaperture for receiving the support structures 310, 315. Such aconfiguration enables the support structures 310, 315 to move relativeto the attachment pads 320, 325, 330, 335 to enable the apical distanceL to be adjusted thereby controlling the position of a papillary musclerelative to an associated annuloplasty device or annulus.

FIG. 4 illustrates a device 400 to control the position of a papillarymuscle including an annulus support anchor according to some embodimentsof the present invention. As shown, device 400 generally includes anannulus anchor 405, a support structure 410, and a papillary muscleattachment system 415. As shown, the annulus anchor 405 is coupled to anannulus 420 of an atrioventricular valve 425, and the papillary muscleattachment system 415 is coupled to a papillary muscle 430 of theatrioventricular valve 420. The device 400 can enable the apicaldistance L between the annulus 420 and the papillary muscle 430 to beadjusted thereby controlling the geometrical shape of the annulus 420and its associated leaflets (not shown).

As shown, the support structure 410 is disposed between the annulus 420and the papillary muscle 430. In some embodiments, the support structure410 may directly anchor to the annulus 420 of the atrioventricular valve420 (without the need for an annuloplasty ring) and in otherembodiments, the support structure 410 can be coupled to an annuloplastyring. The annulus anchor 405 can be many attachment mechanisms thatenable the support structure 410 to be fixedly secured to the annulus405. For example, such attachment mechanisms can include, but are notlimited to, a single or a plurality of hooks, clamping surfaces, or anumbrella type device. Still yet, the annulus anchor 405 can havedivergently extending arm members, such as arm members 406, 407, thatcan extend at least partially around the perimeter of the annulus 420.The arm members 406, 407 can have variable flexibilities to enable thesupport structure 410 to attach at various places along the annulus 405or attach to various types of annuloplasty devices. The annulus anchor405 may be permanently connected to the support structure 410 in someembodiments or may be detachably affixed such that the annulus anchor405 and the support structure 410 can be detached and reattachednumerous times.

As shown, the support structure 410 is also connected to the papillarymuscle 430 via the papillary muscle attachment system 415. The papillarymuscle attachment system 415 can comprise multiple pads, such as a firstpad 435 and a second pad 440, enabling the papillary muscle attachmentsystem 415 to be fixedly secured to or encompass the papillary muscle430. For example, the first pad 435 and the second pad 440 can besutured proximate the papillary muscle 430. Alternatively, the pads 435,440 may not be secured directly to the papillary muscle 430 and may beslidably coupled to the support structure 410. Still yet, one or more ofthe pads can lockably engage the support structure 410 to a certainlength to adjust the apical distance between the annulus 420 and thepapillary muscle 430. This configuration can also enable the pads 435,440 to be axially moved along the axis of support structure 410 toencompass the papillary muscle 430 to alter the shape of the papillarymuscle 430.

The papillary muscle system 415 preferably enables movement of thepapillary muscle 430 relative to the annulus 420. This movement canadjust the apical distance L and enables the geometry of the annulus tobe altered in a manner to control, reduce, or eliminate regurgitationthat may be associated with atrioventricular valve 425. The apicalmovement can occur in various manners according to the variousembodiments of the present invention. For example, the section of thesupport structure 410 disposed between the annulus 420 and the papillarymuscle 430 can be adjusted by moving the first pad 435 and the secondpad 440 along the axis of the support structure. The first pad 435 andthe second pad 440 can have interior apertures located within the firstpad 435 and the second pad 440 that allow the support structure 410 toslidably pass through the first pad 435 and the second pad 440. Once thelength of the support structure 410 has been adjusted to an appropriateamount that corresponds to an optimal apical distance modification, thepads 435, 440 can be used to fix the support structure the appropriateamount. Although the movement of the support structure 410 is discussedas movement based from the papillary muscle 430 other embodiments mayutilize movement based from one or more of the annulus 420 and theannulus anchor 405.

One or both of the first pad 435 and the second pad 440 can also havelocking mechanisms. A locking mechanism enable the pads 435, 440 to lockat a certain point along the axis of the support structure 410. Samplelocking mechanisms can include, but are not limited to, threaded screwdevices, pin locking devices, detent mechanisms, or many othermechanisms capable of applying pressure to the support structure 410.Advantageously, the locking feature enables the device 400 to beadjusted to fix the apical distance L to provide an optimal change tothe morphology of the annulus 420 thereby enabling specific control andposition of the papillary muscle 430 with respect to the annulus 420.

FIG. 5 illustrates a device 500 to control the position of a papillarymuscle according to some embodiments of the present invention. Thedevice 500 generally includes an annular ring 505, a support structure510, a papillary muscle attachment system 515, and a restraint 520.While the restraint 520 is illustrated as an external restraint(positioned outside a valve), the restraint 520 may also be an internalrestraint positioned within a valve. For brevity, certain details of theannular ring 505, the support structure 510, and the papillary muscleattachment system 515 are not discussed in detail with device 500 asthese items can have characteristics and details similar to thecorresponding named components discussed herein. As shown in FIG. 5, theannular ring 505 is coupled to an annulus of a valve and the papillarymuscle attachment system 515 enables a support structure 510 extendingfrom the annular ring 505 to be fixedly attached to a papillary muscle.The restraint 520 partially blocks from view the papillary muscleattachment system 515 since the restraint 520 is an external restraint.

The annular ring 505 can have various characteristics. For example, theannular ring 505 may be a flexible ring, a rigid ring, or a multilinkring. The annular ring 505 may be complete or partial. Also, the ring505 may have a saddle height to commissural ratio between approximately0% and approximately 30%. In one preferred embodiment, the annular ring505 can be composed of titanium wire, stainless steel, Nitnol, otherbiocompatible metals, or combinations thereof. In yet other embodiments,the annular ring 505 may be constructed of a biocompatible polymer. Theannular ring 505 may be covered by a suturing cuff when coupled to anannulus of a valve. The cuff material may be Dacron or otherbiocompatible suture support polymers. The annular ring 505 may beattached to a valve annulus through suture, clamps, titanium clips,hooks, or many other anchoring mechanisms.

The annular ring 505, like rings of other embodiments, can be deployedusing a variety of methods. For example, the annular ring 505 may becollapsed and delivered through a catheter endovascularly or through along arm thorocoscopically. The annular ring 505, if partial, may beextended within a lumen of a catheter during delivery. If the annularring 505 is composed of a series of links, it may be reversibly openedto deliver it using less invasive (or minimally invasive) methodsaccording to some embodiments of the present invention.

The support structure 510 can also have a variety of characteristics.For example, the support structure 510 can be permanently attached tothe annular ring 505. The support structure 510 can also be retractable,and anchored onto the annular ring 505 through a latching, locking, orscrew mechanism. Other mechanisms to attach or couple the supportstructure 510 to the annular ring 505 include screws, clamping, knots,and clips. In one preferred embodiment, the support structure 510 can bea single or a plurality of elongated rods. The support structure 510 maybe rigid, flexible, straight, or curved. Additionally the supportstructure 510 may be formed of a single or plurality of componentmaterials. For example, the support structure 510 can be formed of aplurality of thin metal wires. The support structure 510 can beconstructed using various materials, included but not limited to,titanium, stainless steel, biocompatible alloys, biocompatible polymers,gortex, silk, or other biocompatible materials.

As shown in FIG. 5, the device 500 includes a single support structure510 and use of an annular ring 505. It should be understood, however,that other embodiments of the present invention encompass using multiplesupport structures 510 and not using an annular ring 505. For example,some embodiments comprise a single or a plurality of biocompatiblesupport structures 510 which extend between a valve annulus and apapillary muscle or a ventricular wall. Thus, one end a supportstructure 510 can comprise an anchoring mechanism that can couple thesupport structure 510 to a valve annulus. The anchoring mechanism mayconsist of a series of hooks, clamps, expanding umbrella, or a memoryalloy mesh.

FIG. 5 also illustrates how the restraint 520 can be provided around theexterior of an atrioventricular valve. The restraint 520 can be used tohelp control the lateral distance between papillary muscles (e.g.,medial and lateral papillary muscles) and also in reshaping the exteriorof a valve as it might grow or expand. This lateral distance is labeledas line D_(PM) in FIG. 5. Controlling the lateral distance can assist incontrolling the apical distance between papillary muscles and anassociate valve annulus. It should be understood that a lateral distancecontrol mechanism can also be used in accordance with other embodimentsof the present invention. Other features of the restraint 520 caninclude restricting lateral growth of a valve wall by applying aradially inward force to the valve wall.

The restraint 520 can have additional characteristics. For example, therestraint 520 can be attached at multiple points along the exterior of avalve wall to control the distance between medial and lateral papillarymuscles. As mentioned above, the restraint 520 can also be providedinternally within a valve such that it can be disposed between medialand lateral papillary muscles. For example, in one configuration, aninternal restraint can be a suture or other tension member that iscoupled to the medial and lateral papillary muscles or at positionsalong the valve wall proximate the medial and lateral papillary muscles.The restraint 520 can be made from many materials, and can comprise oneor more materials, including but not limited to, polymer materials, ametallic mesh, and cloth materials.

The restraint 520 can also have an adjustable length. For example, theends of the restraint 520 may be fixedly secured to the papillary muscleattachment system 515. Adjustment of the length of the restraint 520 canoccur when one or both ends of the restraint 520 are moved relative tothe papillary muscle attachment system 515 thereby having a cinchingeffect to decrease the lateral distance D_(PM). Also, in someembodiments, the papillary muscle attachment system 515 can comprise alocking or securing mechanism enabling the length of the restraint 520to be fixed after an optimal length has been obtained. For example, adevice can be at least partially located within a papillary muscle toenable the length of the restraint 520 to be adjusted and then clampedor pinned to have a certain length.

FIG. 6 illustrates a device 600 to control a position of a papillarymuscle including a support structure that does not penetrate a papillarymuscle according to some embodiments of the present invention.Generally, the device 600 comprises an annular ring 605, a supportstructure 610, and a ventrical wall pad 615. In this embodiment, thesupport structure 610 and the ventrical wall pad 615 are adapted so thatthe papillary muscle 620 is not penetrated by the support structure 610.Such a configuration may be advantageous when penetration of a papillarymuscle may not be beneficial for a patient or when movement of apapillary muscle with respect to the support structure 610 may cause thedevice 600 to function improperly.

Because of the placement of the support structure 610 around theexterior of the papillary muscle 620, the shape of the ventrical wallpad 615 can be modified. As shown in FIG. 6, the ventrical wall pad 615is shown to extend below the papillary muscle 620 such that it cups theexterior valve wall proximate the papillary muscle 620. Also, as shown,the ventrical wall pad 615 has a bottom end 625 that is curved to cupthe exterior valve wall. Such configuration of the ventrical wall pad615 ensures that pressure applied to the valve wall does not harm thevalve wall or papillary muscle 620 and sufficiently controls theposition of the papillary muscle 620.

As with other embodiments of the present invention, device 600 ispreferably adapted so that the apical distance L between the annularring 605 and the papillary muscle 620 can be adjusted. Adjusting thisdistance can occur by moving or sliding the ventrical wall pad 615 alongthe axis of the support structure 610. The ventrical wall pad 615,therefore, preferably includes a locking mechanism that enables theventrical wall pad 615 to lock onto a certain point along the axis ofthe support structure 610. This advantageous features enables an optimalapical distance L to be obtained after deployment of device 600. Forexample, after device 600 is surgically deployed within a patient, theapical distance L can be modified such that regurgitation can be reducedor eliminated.

FIG. 7 illustrates a device 700 to control a position of a papillarymuscle using support structures having variable lengths according tosome embodiments of the present invention. Generally, the device 700comprises an annular ring 705, two support structures 710, 711 and anattachment system 715. The support structures 710, 711 are disposedbetween and coupled to the annular ring 705 and the attachment system715. As shown, the attachment system is attached to papillary muscles720. In other embodiments the attachment system 715 can be coupled to aventricular wall. Also, the attachment system 715 may anchor to aventricular wall by being coupled to inner or outer surfaces of aventricular wall. The attachment system 715 may move axially along thelength of the support structures 710, 711 to control the apical distanceL between the papillary muscles 720 and the annulus ring 705.

The attachment system 715 can also comprise other components. Thesecomponents can include a tension member 725 disposed between opposingend members 730, 735. The end members 730, 735 can each compriseapertures to receive the support structures 710, 711. This configurationenables the end members 730, 735 to compress the tension member 725 asthe end members 730, 735 are moved along the axis of the supportstructures 710, 711. Advantageously, this configuration can alsorestrict axial movement of the papillary muscles 720 and/or can enablethe length of the papillary muscles 720 to be controlled. Such aconfiguration may be desired if one of the papillary muscles 720 isdamaged or does not properly function. According to some embodiments,the position of the attachment system 715 along the axis of the supportstructure may also be controlled externally, or outside of the heart.For example, a surgeon could insert an adjustment tool via minimallyinvasive process into a patient (with a beating heart) and use the toolto adjust, or fine tune, the length of the support structures 710, 711to control and eliminate regurgitation.

In other embodiments, the attachment system 715 can be controlledremotely via a remote adjuster outside of a patient's body. Such aremote adjuster may transmit radio frequency signals, microwave signals,or other non-visible energy to activate or instruct the attachmentsystem to adjust the length of on or more of the support structures 710.Thus, the attachment system 715 may comprise a signal receiver ortransmitter to receive such instructions or transmit status informationto a remote adjuster about the attachment system 715 or the patient. Theattachment system 715 can also be used to decrease or increase viaremotes means the length of the papillary muscles 720 by compressing thetissue between the tip of the papillary muscle 720 and a correspondingventricular wall.

As mentioned above, the attachment system 715 may move axially along thelength of the support structures 710, 711. To enable this advantageousfeature, the attachment system 715 may comprise adjustable and lockablemechanisms, such as a first exterior pad 740 and a second exterior pad742. As shown, the first exterior pad 740 is disposed on the exteriorwall of the illustrated valve. The second exterior pad 742 has a firstportion that is disposed on the exterior wall of the illustrated valveand a second portion that is partially disposed within the papillarymuscle.

As shown in the close up illustrations of the pads 740, 742, they havefeatures enabling the pads 740, 742 to lockably engage the supportstructures 710, 711. For example, the first pad 740 can have a notchedinterior aperture to receive a detent member formed on the supportstructure 710. An axial force applied to the support structure 710 canmove detent member of the support structure 710 along the notchedinterior aperture. Also, the second pad 742 can have a pin clamp thatlockably engages the support structure 711. The pin clamp can have ashaft to receive the support structure and a pin 743 that can be pushedtoward and clamp the support structure. As the pads 740, 742 illustrate,some embodiments of the present invention can have support structurelength adjustment mechanisms proximate papillary muscles.

FIG. 8 illustrates a device 800 to control a position of a papillarymuscle using internally threaded support structures according to someembodiments of the present invention. Device 800 generally comprises afirst support structure 810, and a second support structure 815. Thedevice 800 may also comprise annular saddle ring 805 in accordance withsome embodiments of the invention. The device 800 can be deployed in anatrioventricular valve to control, reduce, and eliminate mitralregurgitation associated with the atrioventricular valve by reducing theapical distance between the atrioventricular valve's annulus andpapillary muscles. The annular saddle ring 805 can be sutured orotherwise attached to the annulus, and the support structures 810, 815can be extended in a valve to the valve's papillary muscles. The supportstructures 810, 815 can be coupled to the annular saddle ring 805 viaclamps 815, 835 or many other anchoring or coupling mechanisms. Thesupport structures 810, 815 may be covered with a biocompatible material(such as Goretex) and pierce or penetrate through the valve's papillarymuscles and connect to exterior pads 820, 840 located outside of thevalve's muscle wall.

The support structures 810, 815 can be adapted such their lengths can beadjusted. Adjustment of the lengths of the support structures 810, 815can be utilized to vary the distance between the annular saddle ring 805and the exterior pads 820, 840. Variation of this distance between theannular saddle ring 805 and the exterior pads 820, 840 in turn modifiesthe apical distance between the valve's annulus and papillary muscles.Apical distance modification can result in reshaping the morphology andgeometry of the valve's annulus thereby enabling the leaflets of theannulus to move closer together.

The support structures 810, 815 can have interiors that enable thelength of the support structures to be modified. For example, supportstructure 810 can have an interior 830 with detent members that enablemovement and locking of the interior with corresponding apertures when aforce is applied to an axial force interface member 825. For example,the axial force interface member can be a suture or a wire and whensubjected to an axial force, the length of the support structure 810 canbe reduced so that the annulus saddle ring 805 and the exterior pad 820are moved closer together.

Similarly, support structure 815 can have a threaded interior thatenables rotation of one end of the support structure 815 to be rotatedto adjust the length of the support structure 815. This threadedinterior configuration 830 can enable the length of the supportstructure 815 to be increased and decreased. According to someembodiments, support structure 830 may have a lever 845 at one endcorresponding to pad 840 and rotation of the lever 845 may cause thelength of the support structure 815 to change. In other embodiments, ascrew can be used in the place of the lever 845 and rotation of thescrew can cause the length of support structure 815 to be modified.

The support structures 810, 815 can also have certain internalflexibility characteristics. For example, the support structures 810,815, as illustrated, can have internal spinal structures that enable thesupport structures to flex inward toward each other. Also, the supportstructures 810, 815 can have internal spinal structures that do notpermit the support structures to flex away from each other. In otherembodiments, the support structures 810, 815 can restrict lateral motionfrom one or more of the atrial or ventricular sides within a heart'smitral valve. Such an advantageous feature can, for example, aid inpreventing growth of a heart's ventricle valve wall thus enabling thesupport structures 810, 815 to assist in controlling the position of oneor more papillary muscles.

Exemplary internal spinal structures can comprise a unidirectionalbending structure. This type of bending structure can comprise aplurality of internal components that taper away from the non-flexingdirection. By tapering in the direction of the flexing direction, theinternal spinal structures enable the support structure 810, 815 tocompress. In one configuration, the plurality of internal components cangenerally have a triangular shape. In another configuration, theinternal components can have a cross-section shaped as a “T”.Advantageously, restricting the support structure from flexing can aidin shaping a valve wall and also implanting the device 800 within apatient.

The support structures 810, 815 may also comprise internal securitycharacteristics. As the support structures 810, 815 may fracture orbreak, a security wire may be disposed within the support structures810, 815. The security wire may transverse the entire interior length ofthe support structures 810, 815. Advantageously, a security wire canhold together or collocate any fracture support structure 810, 815pieces because they will be disposed generally around the security wire.

FIG. 9 illustrates yet another device 900 to control a position of apapillary muscle according to some embodiments of the present invention.The device 900 enables adjustment of the position of two papillarymuscles of the mitral valve through the atrium 901 with an adjustmenttool 902. Generally, the device 900 comprises an annular ring 905coupled to papillary muscles A, B via sutures 915, 916 as shown in FIG.9. The device 900 also comprises adjustment mechanisms 909, 910,papillary muscle pad 920, and ventricle wall pad 925. The adjustmentmechanisms 909, 910 can be used to adjust the length of the sutures 915,916. Adjusting the length of the sutures 915, 916 can change theposition of the papillary muscles A, B such that they are closer to theannular ring 905 and the annulus of the mitral valve. The adjustmentmechanisms 909, 910 may be situated proximate the annulus, the papillarymuscles A, B, or both such that adjustment to the length of the sutures915, 916 can be performed in multiple locations.

In some embodiments, adjustment mechanisms 909, 910 may be remotelyadjusted from outside of the body. For example, a remote adjuster (notshown) can be used to activate the adjustment mechanisms 909, 910. Theremote adjuster may transmit radio frequency signals, microwave signals,heat energy, or other invisible energy to the adjustment mechanisms 909,910. The adjustment mechanisms 909, 910 can receive such items and, inresponse, automatically activate the adjustment mechanisms 909, 910 toadjust the length of the sutures 915, 916. Also, the adjustmentmechanisms 909, 910 may transmit status information outside of the bodyto inform about the status of the patient, device 900, adjustmentmechanisms 909, 910, and/or the sutures 915, 916.

The components of device 900 can be implanted within a mitral valve toreduce, control, and eliminate mitral valve regurgitation. The annularring 905 can be sutured to the annulus of the mitral valve. The annularring 905 can be used to change the shape of the annulus and may not beused in all embodiments. The adjustment mechanisms 909, 910 can besecuredly coupled to the annular ring 905. In this embodiment, theadjustment mechanisms are clamped to the annular ring 905. Theadjustment mechanism 909, 910 preferably include internal devices thatenable the length of the sutures 915, 916 to be altered. Also, as shown,both of the adjustment mechanisms are located proximate the atrium ofthe illustrated mitral valve so that they can be adjusted through theatrium. For example, an adjustment tool 902 can be inserted through theatrium 901, as shown, to adjust the length of sutures 915, 916. Havingthe adjustment mechanisms 909, 910 located proximate the atrium 901advantageously enables access to the adjustment mechanisms 909, 910during surgery or post-operative procedures. In other embodiments, theadjustment mechanisms can be located proximate to one or both of thepapillary muscles A, B.

As shown in the close up view of adjustment mechanism 910, an adjustmentmechanism according to certain embodiments of the present can comprisevarious components. As shown, the adjustment mechanism 910 can generallyinclude a clamp 911, a housing 912, an internal threaded bolt 913, andan internal thread nut 914. The internal thread nut 914 can includeattachment points so that the suture 916 can be securedly attached tothe adjustment mechanism 910. The clamp 911 enables the adjustmentmechanism 910 to be securedly attached to an annulus or annuloplastydevice.

As shown, the housing 912 houses the internal threaded bolt 913 and theinternal thread nut 914. The internal thread bolt 913 can be countersunkinto the housing 912. The internal thread bolt 912 can also be rotatablyaffixed to the housing 912 so that the internal thread bolt 919 canrotate within the housing 912. In this exemplary embodiment, theinternal threaded bolt 913 can have a head to communicate with or thatcorresponds to adjustment tool 902. This enables the adjustment tool 902to transfer a mechanical torque force to the threaded bolt 913 forrotation of the threaded bolt 913. The internal thread nut 914 can bedisposed within the housing. The internal thread nut 914 can beinterlocked or in communication with the internal thread bolt 913. Asshown, the internal thread nut can be situated proximate and betweenopposing inner walls of the housing 912. Rotation of the internal threadbolt 913 causes the internal thread nut 914 to move along the length ofthe internal thread bolt 913. In some embodiments, the internal threadnut 914 may be adapted to between approximately 0.1 centimeters toapproximately 5 centimeters. Also, the internal the internal thread bolt913 and the internal thread nut 914 may have very fine thread pitchcounts to enable precise specific movements thereby translating intovery precise changes in the length of the suture 916.

FIG. 9 also illustrates a specific placement of the papillary muscle pad920 which can be utilized in accordance with some embodiments of thepresent invention. The papillary muscle pad 920 can be used to attachthe suture 915 to papillary muscle A. The papillary muscle pad 920, asshown, can be a collar-type device situated proximately around theexterior of the base of papillary muscle A. Alternatively, the papillarymuscle pad 920 may be located at other positions along the exterior ofor at the tip of papillary muscle A. In this embodiment, the papillarymuscle pad 920 is located in the interior of the mitral valve so thatsurrounding areas of the heart are not affected, but in otherembodiments, the papillary muscle pad 920 may be located outside of themitral valve proximate papillary muscle A.

Device 900 also illustrates how a ventrical pad (ventrical wall pad 925)may be disposed or positioned on the exterior of the mitral valveaccording to some embodiments of the present invention. Indeed, asshown, the ventrical wall pad 925 is along the exterior of the mitralvalve proximate papillary muscle B. The ventrical wall pad 925 can besutured or otherwise attached to the exterior wall of the mitral valveat this position. Alternatively, the ventricle wall pad 925 may beaffixed in place via the suture 916. The ventricle wall pad 925 can havemultiple apertures to receive suture 916. Adjustment of the length ofthe suture 916 by reduction can result in cinching effect on papillarymuscle B by a force applied to the ventrical wall pad 925. This cinchingeffect along with a reduction in the length of the suture 916 cancontrol the apical position of the papillary muscle B, and move thepapillary muscle B closer to the annulus of the mitral valve.

As shown in FIG. 9, the sutures 915, 916 generally couple the annulus ofthe mitral valve to the papillary muscles A, B. More specifically, thesutures 915, 916 connect the adjustment mechanisms 909, 910 (which arecoupled to the annulus) to the pads 920, 925 (which are coupled to thepapillary muscles A, B). The sutures 915, 916 are shown in a loopedconfiguration, wherein the sutures 915, 916 are looped around or throughthe pads 920, 925 and the ends of the sutures 915, 916 are connected tothe adjustment mechanisms 909, 910. In other embodiments, the sutures915, 916 may not be looped. Alternatively, other support members can beused in the place of or in concert with the sutures 915, 916, including,but not limited, to wires, elongated rods, biocompatible metal,biocompatible polymer, biocompatible silk, other biocompatiblematerials, collagen, bio-engineered chords, or other bio-engineeredmaterials.

FIG. 10 illustrates a device 1000 to control a position of a papillarymuscle using a compression force according to some embodiments of thepresent invention. The device 1000 generally comprises an interior pad1005, a support structure 1010, an exterior pad 1015, a tension member1020, and a tension control member 1025. As shown, the interior pad 1005can be proximate a tip 1030 of the papillary muscle 1035. The supportstructure 1010 can extend from the interior pad 1005 through thepapillary muscle 1035 to the exterior of a valve wall 1040. The exteriorpad 1015 can be positioned proximate the exterior of the valve wall 1040and the tension member 1025 can be disposed between the exterior pad1015 and the tension control member 1025. The support structure 1010 canbe coupled to one surface of the interior pad 1005, and be placed withinapertures located within the exterior pad 1015 and the tension controlmember 1025.

The length of papillary muscle 1035 can be controlled using the device1000. For example, tension control member 1025 can be adjusted to movecloser to the interior pad 1005 and such movement can decrease thelength of the support structure 1010 between interior and exterior pads1005, 1015. This decreased length in turn can compress the papillarymuscle 1035 in a manner that can control the tip 1030 of the papillarymuscle 1035 relative to an associated annulus.

The device 1000 can have various applications according to embodimentsof the present invention. The device 1000 can be used as a stand alonedevice or in conjunction with a device such as that illustrated in FIG.4 with a single support structure. In such a configuration, the devices400, 1000 can form a system which can compress a first papillary muscleto control the position of a valve annulus in addition to apicallyadjusting a second papillary muscle. The device 1000 can also be used tocontrol the length or shape of a papillary muscle in some embodiments.

FIG. 11 illustrates a device 1100 to control a position of a papillarymuscle using a compression force according to some embodiments of thepresent invention. The device 1100 is similar in operation to the device1000 illustrated in FIG. 10, so for brevity the same reference numeralsare used in FIG. 11 for corresponding features shown and described abovewith reference to FIG. 10. One difference between FIG. 10 and FIG. 11 isthat the support structure 1010 in FIG. 10 penetrates the papillarymuscle 1035 and the support structure 1010 in FIG. 9 does not penetratethe papillary muscle 1035. Rather, the support structure 1110 of device1100 illustrated in FIG. 11 is positioned along the exterior of thepapillary muscle 1035. This configuration is beneficial and advantageousbecause it may be desired when penetrating a papillary muscle is notrequired. Also, this configuration may be desired to assist incontrolling a papillary muscle having reduced functionality. The supportstructure 1110 of device 1100 can also be different in that it can havean interior pad 1105 that curves around the tip 1030 of the papillarymuscle 1035 as shown in FIG. 11.

FIG. 12 illustrates a logical flow diagram depicting a method 1200embodiment of the present invention capable of reforming a mitral valveby controlling position of an associated papillary muscle. According tosome method embodiments the complete implant or partial sections may bedelivered percutaneously, and in other embodiments, the complete implantor partial sections may be delivered thorocoscopically in a beatingheart. Those skilled in the art will understand that the method 1200 isonly one method embodiment of the present invention and that the method1200 can have various steps or be performed in various orders.

The method 1200 can initiate at 1205 during a surgical operation beingperformed on a patient. The surgical operation may be an open heartsurgery to fix or repair a patient's heart or to correct regurgitationassociated with an atrioventricular valve, such as a mitral valve. Inother embodiments, the surgical operation may be performed utilizingminimally invasive techniques in which surgical implants are insertedinto a patient using lumens. The method 1200 can continue at 1210 wherea patient's heart may be stopped and bypassed by a surgeon so that apapillary muscle control device can be deployed or implanted within thepatient's heart. The method 1200 may also be performed on a beatingheart and in such an instance and bypass of the heart may not occur.

Next, the papillary muscle control device can be deployed within apatient's heart in an effort to control, reduce, and eliminateregurgitation. The papillary muscle control device can be one of theexemplary embodiments discussed above, such as those illustrated inFIGS. 2-11. The papillary muscle control device may be implanted in avariety of manners and the implantation may depend on the utilizedsurgical procedure, health of the patient, or other factors. Forexample, and according to the method 1200, that papillary muscle controldevice may be attached (or anchored) to at least one of a valve annulusor an annuloplasty device at 1215.

That is, in some embodiments, the papillary muscle control device may bedirectly attached to a valve annulus, attached directly to anannuloplasty device, or both. The papillary muscle control device can beanchored using clamps, sutures, hooks, crimps, or other couplingmechanisms. If attached to an annuloplasty device, the papillary musclecontrol device may be permanently coupled to the annuloplasty device orcapable of being attached and reattached to the annuloplasty device.Also, the annuloplasty device may be pre-implanted within a patient orimplanted during the method 1200.

After the papillary muscle control device is connected to at least oneof a valve annulus or an annuloplasty device, the papillary musclecontrol device can then be connected to at least one papillary muscle at1220. Connecting the papillary muscle control device in this manner inturn couples at least one papillary muscle to at least one of a valveannulus or annuloplasty device at 1225. Advantageously, connecting thepapillary muscle control device in this manner can adjust or move apapillary muscle to rectify abnormal movement of the papillary muscle.Indeed, connecting the papillary muscle control device to a papillarymuscle enables the position of the papillary muscle to be controlled andmoved apically toward a valve annulus so that an initial apicaladjustment occurs at 1230. The inventors have discovered thatcontrolling the movement of a papillary muscle in an apical directioncan alter leaflet geometry.

The papillary muscle control device can have various connection andfunctional characteristics. For example, the papillary muscle controldevice can have multiple connection structures. These multipleconnection structures can enable connection or coupling between a valveannulus and to two papillary muscles. Also, the papillary muscle controldevice preferably comprises connection structures capable of havingadjustable lengths. For example, the connection structures themselvescan incorporate multiple parts that interact to alter the length of theconnections structures (e.g., an interior threaded configuration).Alternatively, the papillary muscle control device can have lengthadjustment mechanism that adjust the apical distance between a papillarymuscle and valve annulus by movement along the length of a supportstructure.

The length adjustment mechanism can interact with (e.g., slidablyengage) a support structure so that the apical distance can be varied toan optimal length. The optimal length may be the length that eliminatesregurgitation or controls regurgitation to a sufficient amount. Thelength adjustment mechanism can also have a locking mechanism (e.g., pinlock, detent member, or clamp) that can fix the length of the supportstructure at the optimal length. The length adjustment mechanism can belocated proximate a valve annulus, proximate a papillary muscle, or bothaccording to the various embodiments of the present invention. Thus, thelength adjustment mechanism can be utilized to adjust the length of asupport structure so that the apical distance between a papillary muscleand valve annulus is modified to reduce regurgitation.

After implantation of the papillary muscle control device, the surgicaloperation can be completed at 1235. If the surgical operation requiredstopping of a patient's heart, then the patient's heart can be restartedat this time. Preferably, the patient's heart will then be allowed tooperate for approximately five minutes so that the function of the heartat this time can be close to normal operation. After waiting, furtheradjustments can be made to the papillary muscle control device at 1240.These adjustments, for example, can be made as a surgeon analyzesDoppler regurgitation results. Advantageously, this feature enables finetuning of the papillary muscle control device on a beating heart. Alsothis feature enables apical adjustment of a papillary muscle in realtime while monitoring regurgitation data to control, reduce, oreliminate regurgitation.

It should be understood that these further adjustments can be made atany time post-operation. For example, after waiting several minutes, asurgeon can perform the adjustments. Alternatively, the adjustments tothe papillary muscle control device may occur days, months, or yearsafter successful conclusion of a surgery and after a patient has healed.This would enable a surgeon to use minimally invasive procedures toaccess the papillary muscle control device to alter the length of asupport structure thereby altering the apical distance of a papillarymuscle relative to a valve annulus. Thus, adjustments to the papillarymuscle control device can be repeated at 1245 as needed to control heartvalve regurgitation at 1245 to complete method 1200 at 1250.

The embodiments of the present invention are not limited to theparticular exemplary embodiments, process steps, and materials disclosedherein as such embodiments, process steps, and materials may varysomewhat. Moreover, the terminology employed herein is used for thepurpose of describing exemplary embodiments only and the terminology isnot intended to be limiting since the scope of the various embodimentsof the present invention will be limited only by the appended claims andequivalents thereof.

Thus, while the various embodiments of this invention have beendescribed in detail with particular reference to exemplary embodiments,those skilled in the art will understand that variations andmodifications can be effected within the scope of the invention asdefined in the appended claims. Accordingly, the scope of the variousembodiments of the present invention should not be limited to the abovediscussed embodiments, and should only be defined by the followingclaims and all equivalents.

We claim:
 1. A method for treating mitral valve disease in a heart, themethod comprising: accessing a heart by minimally invasive surgery;fixing a first anchor at a mitral valve in a heart, the first anchorincluding a cover comprising a suturable layer; extending a suture of atleast one support structure through a left ventricular wall, a first endof the at least one support structure secured to the first anchor;positioning a second anchor against an exterior of the left ventricularwall, the second anchor including an aperture through which the sutureslidably extends; adjusting a length of the at least one supportstructure between the first anchor and the second anchor whilemonitoring an effect of the adjusting on the beating heart, wherein theadjusting includes sliding the suture relative to the second anchor; andlocking the suture at the second anchor, thereby fixing the length ofthe at least one support structure between the first anchor and thesecond anchor, wherein locking the suture includes engaging the suturewith a locking mechanism of the second anchor.
 2. The method of claim 1,wherein fixing the first anchor includes attaching the first anchor toan annulus of the mitral valve.
 3. The method of claim 1, whereinextending the suture of the at least one support structure includesextending a suture of a first support structure and a suture of a secondsupport structure.
 4. The method of claim 1, wherein positioning thesecond anchor includes positioning a second anchor including a portioncurved to cup the exterior ventricular wall.
 5. A method for treating adiseased atrioventricular valve in a heart, the method comprising:fixing a first anchor at an atrioventricular valve in a heart; extendingat least one support structure through a ventricular wall, a first endof the at least one support structure secured to the first anchor;positioning a second anchor against an exterior of the ventricular wall;adjusting a length of the at least one support structure between thefirst anchor and the second anchor while the heart is beating; andlocking the at least one support structure at the second anchor, therebyfixing the length of the at least one support structure between thefirst anchor and the second anchor.
 6. The method of claim 5, furthercomprising accessing the heart by minimally invasive surgery.
 7. Themethod of claim 5, wherein fixing a first anchor at the atrioventricularvalve includes fixing the first anchor at a mitral valve.
 8. The methodof claim 5, wherein fixing the first anchor includes attaching the firstanchor to an annulus of the atrioventricular valve.
 9. The method ofclaim 8, wherein attaching the first anchor includes attaching anannuloplasty ring.
 10. The method of claim 5, wherein fixing the firstanchor includes fixing a first anchor including a cover comprising asuturable layer
 11. The method of claim 5, wherein extending at leastone support structure through a ventricular wall includes extending asuture of the at least one support structure through the ventricularwall.
 12. The method of claim 5, wherein extending the at least onesupport structure includes extending the at least one support structurethrough or proximate to a papillary muscle.
 13. The method of claim 12,wherein extending the at least one support structure through orproximate to the papillary muscle includes extending the at least onesupport structure through a pad contacting the papillary muscle or innerventricular wall.
 14. The method of claim 5, wherein extending at leastone support structure includes extending a first support structure and asecond support structure.
 15. The method of claim 5, wherein positioningthe second anchor includes positioning a second anchor comprising anaperture through which the at least one support structure slidablyextends.
 16. The method of claim 5, wherein positioning the secondanchor includes positioning a second anchor including a portion curvedto cup the exterior ventricular wall.
 17. The method of claim 5, whereinadjusting the length of the at least one support structure furthercomprises monitoring an effect of the adjusting on the beating heart.18. The method of claim 17, wherein monitoring the beating heartincludes monitoring the beating heart by Doppler.
 19. The method ofclaim 5, wherein locking the at least one support structure includesengaging the at least one support structure with a locking mechanism ofthe second anchor.